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BijinV replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 7 years, 6 months ago
The primary difference between project management for medical devices and other non-medical companies is the adherence to regulations set forth by the FDA. Due to the fact that medical devices are ultimately intended for human use, there are much tighter regulations placed on safety. As someone who works in such an environment, safety and efficacy are at the very forefront of every endeavor my company undertakes. In addition, all the equipment we use must be qualified and validated before any sort of clinical work can begin. This again is to satisfy FDA regulations in order to protect patients, users, and trial participants. The primary phases of project management are probably largely similar, but the detail and attention devoted to safety and protection are paramount in medical devices.